LEEP PRECISION Integrated System and Generator 2019-06-02)
- Starting date:
- June 2, 2019
- Posting date:
- June 14, 2019
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-70215
Last updated: 2019-06-14
Affected Products
A. LEEP PRECISION Integrated System
B. LEEP PRECISION Generator
Reason
CooperSurgical is conducting a medical device safety alert for five (5) LEEP PRECISION Integrated System and generator units distributed to Canada (358 total units distributed) because of the possibility that the generator may lose power intermittently when using the foot pedal. The LEEP PRECISION Integrated System unit will then cease to cut, coagulate, or blend tissue during a procedure.
Affected products
A. LEEP PRECISION Integrated System
Lot or serial number
2015110019
2017050005
Model or catalog number
LP-10-120
Companies
- Manufacturer
-
Coopersurgical Inc.
95 Corporate Drive
Trumbull
06611
Connecticut
UNITED STATES
B. LEEP PRECISION Generator
Lot or serial number
2016080033
0036
2016100033
Model or catalog number
LP-20-120
Companies
- Manufacturer
-
Coopersurgical Inc.
95 Corporate Drive
Trumbull
06611
Connecticut
UNITED STATES